# K081984: Laborpro System

- Pathway: 510(k) (Traditional)
- Applicant: Trig Medical, Ltd.
- Decided: Mar 4, 2009 after 236 days
- Product code: NPB (System, Monitoring, For Progress Of Labor)
- Device class: 2
- Regulation: 21 CFR 884.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K882383 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN060006: Computerized Labor Monitoring System, Barnev, Ltd. (2007). Our reading of the summary gave K060028, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN060006, Computerized Labor Monitoring System (Barnev, Ltd.), granted Jan 30, 2007; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K023227: USG 2000SA, Ultraguide, Ltd. (2002) Summary page 1.
- (no number) pelvimeters: named in the summary without a submission number
- (no number) Cervilenz Measuring Sound: named in the summary without a submission number

## Indications for use
The LaborPro System is intended for monitoring the active phase of labor in women with term gestations and a singleton fetus in vertex presentation. The device intermittently assesses fetal head station, position and cervical dilation. Cervical dilation using LaborPro is assessed using position sensors during vaginal examination. The LaborPro also may be used to measure cervical length, pubic arch angle and interspinous diameter using position sensors during vaginal examination. The LaborPro combines a magnetic tracking system including a transmitter and position sensor with an ultrasound imaging system (not included with the LaborPro). Measurements are displayed numerically and graphically as a function of time to show the progress of labor.

Source page: https://510kreport.com/device/K081984
Methodology: https://510kreport.com/methodology